Risk Management for Medical Devices – A Compliance Primer

Teachers
Dan O’Leary
Category:
Med Device/ Regulatory & Compliance/ Introductory Courses/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Risk Management is vital in medical device design, manufacturing, and post-market surveillance.  The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system.  The FDA recognizes ISO 14971:2007 as a consensus standard.  ISO 13485:2003 also calls out the standard as the preferred method.  In the European Union, EN ISO 14971:2012 is a harmonized standard and notified bodies will expect full compliance.  This can be confusing for the uninitiated, but LSTI offers a convenient online solution to get you and your colleagues up to speed with risk management principles for medical devices.

LEARNING OBJECTIVES

Join our online training course where you will learn:

  1. An overview of ISO 14971 to place the presentation in context – build your foundation
  2. FDA requirements for risk analysis as part of design validation – what you must know
  3. Recognition status of ISO 14971 by the FDA and for the EU MDD
  4. The GHTF guidance document on risk management principles
  5. Developing a risk evaluation for your product – implementing strategies for success

Who Should Attend

WHO SHOULD ATTEND

This course is for quality, regulatory, production, and design people involved in risk analysis or Risk Management.  Because risk management is a life cycle approach, sales and service people may also benefit.

Because of the cross functional and cross discipline aspects, this is an ideal opportunity for team attendance.  Since you need to ensure that all parties get the same message, people in the following roles will gain particular benefit from attending:

  1. Risk Managers
  2. Validation Professionals
  3. Design Engineers
  4. Project Managers involved in Design and Development
  5. Quality Engineers assigned to validation activities
  6. Quality Auditors
  7. Quality staff assigned to Customer Complaints or CAPA management

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Dan O’Leary
Focuses on operations management for small manufacturing companies, including quality assurance, quality management, production planning, inventory management, and health/safety.

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